Drugs / Levocabastine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) LIVOSTIN — 1996-06-10 fda.gov ↗
Approved US (FDA) LIVOSTIN — 1993-11-10 fda.gov ↗

Trials 4

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01962467 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed No outcome recorded
Phase 22 trials · 2 met primary
Phase 2 NCT01949051 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed Met primary
Phase 2 NCT01957202 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed Met primary
Phase not applicable1 trial
— NCT04002349 Jul → Dec 2019 — Beijing Tongren Hospital Unknown No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT02498509 Comparator May 2015 → Mar 2016 perennial allergic rhinitis Chong Kun Dang Pharmaceutical Completed No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Levocabastine “A Relative Bioavailability Study to Compare the Pharmacokinetics of a Fixed Dose Combination of Fluticasone Furoate and Levocabastine With Levocabastine and Fluticasone Furoate Alone” NCT01962467 ↗
3

NCT01957202 ↗

NCT04002349 ↗

NCT01949051 ↗

Known as LEV “The purpose of the study is to determine the relative bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is administered alone and as FF/LEV Fixed...” NCT01962467 ↗
Known as LEVO “OBJECTIVES: To test the hypothesis that intranasal levocabastine (LEVO) may provide benefits as a oncedaily treatment in allergic rhinitis (AR), this non-inferiority study...” PMID 26249767 ↗ Oct 2015
1

“OBJECTIVE: To compare the effects of intranasal fluticasone furoate (FF)/levocabastine (LEVO) fixed-dose combination (FDC) with each component alone” PMID 25900517 ↗ Aug 2015

Known as Levocabastina ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438 ↗
Known as Levocabastine HCL ClinicalTrials.gov intervention name — accepted as the source's own label NCT02498509 ↗
Known as LEVOCABASTINE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438 ↗
Known as Livostin ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438 ↗
Known as Livostin direct ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438 ↗
Known as Livostine “Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)” NCT04002349 ↗
Known as Livostinet “Levocabastine(Livostinet, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) Nasal Spray” NCT04002349 ↗
Known as R 50,547 ChEMBL registry synonym — accepted as the source's own label CHEMBL1615438 ↗
Action Inhibit “Histamine H1 receptor antagonist” CHEMBL1615438 ↗
Modality Small molecule — CHEMBL1615438 ↗
Route Intranasal “Intranasal aqueous 50 mcg microsuspension of levocabastine” NCT01949051 ↗
Target HRH1 “Histamine H1 receptor antagonist” CHEMBL1615438 ↗